In addition to meeting the requirements of COMAR 30.08.11, a designated thrombectomy-capable primary stroke center hospital shall: Be designated by MIEMSS as a primary stroke center at the time of application for designation as a thrombectomy-capable primary stroke center; Continue to meet the primary stroke center requirements in COMAR 30.08.11 to the extent such requirements are consistent with designation as a thrombectomy-capable primary stroke center; Require each physician who performs mechanical thrombectomy to have performed 15 mechanical thrombectomies over the past 12 months or 30 over the past 24 months, which may include procedures performed at other facilities; Perform mechanical thrombectomy and have provided post-procedure care for a minimum of 15 patients in the past 12 months or at least 30 patients over the past 24 months; Meet the requirements of Regulations .01—.15 of this chapter; Satisfy the MIEMSS requirements for designation as a thrombectomy-capable primary stroke center by MIEMSS; and Meet the requirements for a site review in COMAR 30.08.02.06, which may be satisfied by completing either: An on-site review by MIEMSS; or A site survey as part of The Joint Commission Disease Specific Care Certification Program for certification as a thrombectomy-capable primary stroke center if the hospital: Authorizes The Joint Commission to provide MIEMSS with survey findings, certification reports, and other information related to The Joint Commission’s certification of the hospital as a thrombectomy-capable primary stroke center; Allows MIEMSS to participate in the accreditation site survey; and Provides MIEMSS any additional information required to determine that the hospital has satisfied the requirements for designation under this chapter. A hospital designated as a thrombectomy-capable primary stroke center shall meet the requirements of COMAR 30.08.11.02. The emergency department of a hospital designated as a thrombectomy-capable primary stroke center shall meet the requirements of COMAR 30.08.11.03 The operating room of a hospital designated as a thrombectomy-capable primary stroke center shall meet the requirements of COMAR 30.08.11.04 In addition to meeting the requirements of COMAR 30.08.11.05, the acute stroke team shall include at a minimum: A physician, with special competence in caring for an acute stroke patient, who is Board-certified or Board-eligible in: Neurology; Critical care medicine; Emergency medicine; or Internal medicine; and At least one additional health care provider, with experience in caring for the acute stroke patient, who may be: An emergency physician; An internal medicine physician; A neurology resident or fellow; A registered nurse; A physician’s assistant; or A nurse practitioner. If a physician otherwise satisfies §A(1) of this regulation but is not Board-certified or Board-eligible in neurology, a Board-certified or Board-eligible neurologist shall be available within 15 minutes for consultation under the terms of a written agreement by: Telephone; or Audio/visual communication. A hospital designated as a thrombectomy-capable primary stroke center shall maintain an intensive care unit that: Has designated beds for the care of the acute stroke patient; Has 24/7 on-site practitioners with critical care privileges, including, for example, APNs, PAs, fellows, or residents; Provides care to acute stroke patients through qualified clinical staff who meet the requirements in Regulation .11 of this chapter; Follows standardized processes derived from evidence-based clinical practice guidelines to facilitate clinical care; Incorporates individualized plans of care that are based on the patient’s assessed needs and reflect coordination of care with other programs, as determined by patient comorbidities; Has a process to assess the abilities and resources of family members to be involved in post-acute care; and Maintains written documentation delineating the function of the intensive care unit, including: Admission criteria; Discharge criteria; Acute stroke care protocols; Interdisciplinary rounding; Rehabilitation assessment and services in the hospital; and Outcome data. The stroke unit of a hospital designated as a thrombectomy-capable primary stroke center shall meet the requirements of COMAR 30.08.11.07. A hospital designated as a thrombectomy-capable primary stroke center shall meet the requirements of COMAR 30.08.11.08. In addition to meeting the requirements of COMAR 30.08.11.09, a hospital designated as a thrombectomy-capable primary stroke center shall have the following diagnostic capability available when indicated: Carotid duplex ultrasound; Transcranial ultrasonography; and Transesophageal/transthoracic echocardiogram. A hospital designated as a thrombectomy-capable primary stroke center shall have: Interventional services promptly available 24 hours a day with appropriately trained support staff and necessary equipment; Interventional services that include: Intra-arterial reperfusion therapy; and Stenting/angioplasty of intracranial vessels; A neurointerventionalist who may be a Board-certified/Board-eligible neuroradiologist, neurologist, or neurosurgeon on-call with a 45-minute arrival time to the hospital; An on-call schedule for a primary and a back-up neurointerventionalist; and A written protocol to accept the inter-facility transfer of acute ischemic stroke patients requiring endovascular therapy that includes communication and feedback to the sending facility. In addition to meeting the requirements of COMAR 30.08.11.10, a neurointerventionalist shall have: 4 or more hours of category 1 or 2 CME credits per year related to stroke care; and Performed 15 mechanical thrombectomies over the past 12 months or 30 over the past 24 months. In addition to meeting the requirements of COMAR 30.08.11.11, the emergency department clinical staff who triage or care for acute stroke patients shall be educated, by the hospital, on mechanical thrombectomy protocols. A hospital designated as a thrombectomy-capable primary stroke center shall meet the requirements of COMAR 30.08.11.12. In addition to meeting the requirements of COMAR 30.08.11.13, a hospital designated as a thrombectomy-capable primary stroke center shall: Have written policies ensuring that: Transfer of patients from another facility is appropriate and patients are received in a timely manner; and All stroke patients will receive medical care commensurate with the hospital’s designation as a thrombectomy-capable primary stroke center; Have written procedures demonstrating the ability to care for two complex interventional radiology stroke patients at one time, using appropriate clinical staff; Have written documentation demonstrating on-call and back-up on-call schedules for physicians and staff for 24/7 coverage; Have written care protocols for advanced treatment of complex stroke patients, including, but not limited to, acute ischemic stroke patients and acute intra-arterial therapeutic interventions; and Document and review the scope of practice and the roles and responsibilities of nurse practitioners and physician assistants providing care to the acute stroke patient in the intensive care unit, the emergency department, and the stroke unit. In addition to meeting the requirements of COMAR 30.08.14, a hospital designated as a thrombectomy-capable primary stroke center shall: Monitor and demonstrate 24-hour post-procedure stroke and death rates of less than or equal to 1 percent for diagnostic neuro-angiography; Monitor documentation of the reasons potentially eligible ischemic stroke patients did not receive mechanical thrombectomy; Monitor and demonstrate tracking and trending of modified Rankin Scores (mRS) at 90 days post-discharge on patients with acute ischemic stroke who received mechanical endovascular reperfusion therapy; In cases where mechanical endovascular reperfusion therapy is appropriate, achieve door-to-device times, arrival to first pass of thrombectomy device, in 50 percent or more of eligible acute ischemic stroke patients within 120 minutes for direct arriving patients and within 60 minutes for inter-facility transfer patients treated with endovascular therapy; and Demonstrate progress towards reducing door-to-device times, arrival to first pass of thrombectomy device in 50 percent or more of eligible acute ischemic stroke patients within 90 minutes for direct arriving patients. Education Article, §13-509, Annotated Code of Maryland Effective date: January 1, 2022 (48:22 Md. R. 939)